K242154
- 510(k) number
- K242154
- Device name
- Numen Coil Embolization System; NumenFR Detachment System
- Applicant
- MicroPort NeuroTech (Shanghai) Co., Ltd. CN
- Product code
- HCG — Device, Neurovascular Embolization
- Decision date
- 2024-09-30
- Date received
- 2024-07-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K242154.pdf
Official FDA record: K242154
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.